POSITIVE Trial

Condition/Intervention:

  • Stroke

Study Name:

Perfusion Imaging Selection of Ischemic Stroke Patients for Endovascular Therapy

Phase:

Phase 3

Summary:

The purpose of this study is to assess the safety and effectiveness of the mechanical thrombectomy (physically removing a blockage in a blood vessel) compared to best medical therapy (treatment with the best use of available medicines) in stroke subjects who are able to begin treatment within 12 hours of symptom onset.

The devices used in this study have been approved by the U.S. Food and Drug Administration (FDA) for opening clotted blood vessels in the brain, but researchers will test investigational ways of using these devices. Researchers may also use more than one device in combination, instead of a single device at a time as approved by FDA.

Financial disclosure: Dr. Alexander receives compensation from the company sponsoring the study. This includes consulting fees and fees for speaking engagements.

Key Inclusion Criteria:

  • Age 18 to 80 years
  • National Institutes of Health Stroke Scale greater than or equal to eight
  • Presenting or persistent symptoms within 12 hours of when groin puncture can be obtained
  • Neuroimaging demonstrates large vessel proximal blockage
  • The stroke can be appropriately treated with traditional endovascular techniques

Key Exclusion Criteria:

  • Eligible for intravenous tissue plasminogen activator therapy
  • Rapidly improving neurologic examination
  • Absence of large vessel occlusion on non-invasive imaging
  • Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
  • Absence of an associated large penumbra

Please see complete list of inclusion and exclusion criteria.

Principal Investigator:

Michael Alexander, MD

Co-Investigators:

Paula Eboli, MD
Patrick Lyden, MD
Shlee Song, MD
Sam Torbati, MD

Study Coordinator and Contact:

Vicki Manoukian
Phone: 310-423-5067
Email: vicki.manoukian@cshs.org

Status:

Active

IRB No.:

36183

Date Last Updated:

05/15